(188 days)
Not Found
No
The summary describes basic audio processing, filtering, and visualization features, but does not mention any AI or ML algorithms for analysis or interpretation of the sounds.
No
The device is intended for medical diagnostic purposes only, specifically for detection, amplification, and analysis of sounds from the heart and lungs, which falls under diagnostic, not therapeutic, use.
Yes.
The "Intended Use / Indications for Use" section explicitly states "Stethophone v1 is intended for medical diagnostic purposes only."
No
The device description explicitly states it is an "electronic stethoscope software application that operates on smartphones" and acquires sound through the "smartphone microphone." While the core functionality is software, it relies on the smartphone's hardware (microphone) for data acquisition, making it a combination product or a device that utilizes existing hardware, not a purely software-only medical device. The predicate devices also include hardware components (electronic stethoscopes).
Based on the provided information, the Stethophone v1 is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. This typically includes blood, urine, tissue, etc.
- The Stethophone v1 analyzes sounds produced by the human body. It captures and processes acoustic signals from the heart and lungs.
The Stethophone v1 is a medical device used for physical assessment and decision support based on auscultation (listening to internal body sounds). It falls under the category of electronic stethoscopes, as evidenced by its predicate devices.
N/A
Intended Use / Indications for Use
Stethophone v1 is intended for medical diagnostic purposes only. It may be used for detection and amplification of sounds from the heart and lungs with the use of selective frequency ranges. It can be used on adults undergoing physical assessment.
Product codes
DQD
Device Description
Stethophone v1 is an electronic stethoscope software application that operates on smartphones. Stethophone v1 allows for the capture and amplification of chest sounds that are listened in real-time or recorded, cloud storage of sound records, sound filtering for selected frequency ranges, and visualization to assist in sound analysis.
Stethophone v1 is designed to assist healthcare providers to hear and visualize heart and lung sounds during a physical examination of a patient as well as storing recorded sounds for later analysis. Stethophone v1 is a decision support device used for the assessment of chest sounds of adult patients in clinical and non-clinical environments. Key product features:
- Acquiring sound through the smartphone microphone
- Real-time listening of chest sounds
- Recording of chest sounds
- Two modes of sound visualization: oscillogram and spectrogram
- Selecting among three sound filters for listening:
- Bell: Classic filter used for low frequency sounds
- Diaphragm: Classic filter used for higher frequency sounds of heart and lungs
- Starling: Filter for listening to the full frequency of chest sounds
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Heart and lungs
Indicated Patient Age Range
Adults
Intended User / Care Setting
Stethophone v1 is designed to assist healthcare providers... in clinical and non-clinical environments.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Sparrow Acoustics Inc. submitted performance testing information in this 510(k) to demonstrate safety and efficacy of Stethophone v1, to validate that the device meets predetermined specifications and performs according to pre-specified acceptance criteria, and to support the substantial equivalence determination.
Testing includes repeatability and reproducibility tests, performance tests using an anechoic chamber, internal tests run by a medical analysts' team, tests involving external medical specialists with auscultation experience, as well as a usability and performance study conducted by an independent medical facility.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1875 Stethoscope.
(a)
Manual stethoscope —(1)Identification. A manual stethoscope is a mechanical device used to project the sounds associated with the heart, arteries, and veins and other internal organs.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.(b)
Electronic stethoscope —(1)Identification. An electronic stethoscope is an electrically amplified device used to project the sounds associated with the heart, arteries, and veins and other internal organs.(2)
Classification. Class II (special controls). The device, when it is a lung sound monitor, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The text is arranged in two lines, with "FDA" being larger and bolder than the rest of the text.
March 29, 2023
Sparrow Acoustics Inc. Nadezda Ivanova Chief Product Officer 2416 Natura Drive Lucasville, NS B4B 0X3 Canada
Re: K222871
Trade/Device Name: Stethophone v1 Regulation Number: 21 CFR 870.1875 Regulation Name: Stethoscope Regulatory Class: Class II Product Code: DQD Dated: September 21, 2022 Received: September 22, 2022
Dear Nadezda Ivanova:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Robert T. Kazmierski -S
for
LCDR Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics, and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K222871
Device Name
Stethophone v 1
Indications for Use (Describe)
Stethophone v1 is intended for medical diagnostic purposes only. It may be used for detection and amplification of sounds from the heart and lungs with the use of selective frequency ranges. It can be used on adults undergoing physical assessment.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/1 description: The image shows the logo for Sparrow Acoustics. The word "SPARROW" is written in a sans-serif font in a light blue color. To the right of the word "SPARROW" is a graphic of a bird inside of a circle with sound waves emanating from it. Below the word "SPARROW" is the word "ACOUSTICS" written in a smaller sans-serif font.
510(k) SUMMARY
-
- Summary Date: September 21, 2022
-
- Submitter: Sparrow Acoustics Inc. 2416 Natura Dr. Lucasville, NS Canada. B4B 0X3 Tel: +1 (902) 989-3908
-
- Correspondent: Nadia Ivanova
-
- Device Trade Name: Stethophone v1
-
- Device Common Smartphone stethoscope Name:
-
- Classification: Electronic Stethoscope 21 CFR 870.1875(b) Class II Product Code: DQD Panel: Cardiovascular
-
- Intended Use/ Stethophone v1 is intended for medical diagnostic purposes only. It may be used for the detection and amplification of sounds from the heart and Indications for Use: lungs with the use of selective frequency ranges. It can be used on adults undergoing physical assessment.
-
- Device Description: Stethophone v1 is an electronic stethoscope software application that operates on smartphones. Stethophone v1 allows for the capture and amplification of chest sounds
that are listened in real-time or recorded, cloud storage of sound records, sound filtering for selected frequency ranges, and visualization to assist in sound analysis.
Stethophone v1 is designed to assist healthcare providers to hear and visualize heart and lung sounds during a physical examination of a patient as well as storing recorded sounds for later analysis. Stethophone v1 is a decision support device used for the assessment of chest sounds of adult patients in clinical and non-clinical environments. Key product features:
- Acquiring sound through the smartphone microphone ●
- Real-time listening of chest sounds .
- Recording of chest sounds .
- Two modes of sound visualization: oscillogram and spectrogram ●
- Selecting among three sound filters for listening: ●
- Bell: Classic filter used for low frequency sounds O
- Diaphraqm: Classic filter used for higher frequency sounds of O heart and lungs
- Starling: Filter for listening to the full frequency of chest sounds O
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Image /page/4/Picture/1 description: The image shows the logo for Sparrow Acoustics. The word "SPARROW" is written in a large, sans-serif font in a light blue color. To the right of the word "SPARROW" is a stylized image of a bird inside of a circle with sound waves emanating from it. Below the word "SPARROW" is the word "ACOUSTICS" written in a smaller, sans-serif font.
| 9. | Predicate Devices: | Steth IO® Smartphone Stethoscope
and Phonocardiogram, Model 1.0 | 3M™ Littmann® Electronic
Stethoscope, Model 3200 |
|-----|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|
| | | 510(k) Number: K160016
Manufacturer: StratoScientific, Inc.
Product Code: DQD
Classification: 870.1875(b) | 510(k) Number: K083903
Manufacturer: 3M Company
Product Code: DQD
Classification: 870.1875(b) |
| 10. | Comparison to
Predicates: | The comparison chart below provides evidence to facilitate the
substantial equivalence determination between Stethophone v1 to the
predicate devices with respect to intended use, technological
characteristics, and principles of operation. | |
| | Stethophone v1 | Steth IO®
(primary) | 3M™ Littmann®
Model 3200 | Comments |
|-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification | | | | |
| Classification | Class II device | Class II device | Class II device | Same |
| Regulation | 21 CFR
870.1875(b) | 21 CFR
870.1875(b) | 21 CFR
870.1875(b) | Same |
| Product code | DQD | DQD | DQD | Same |
| Device | Stethoscope,
Electronic | Stethoscope,
Electronic | Stethoscope,
Electronic | Same |
| FDA Clearance | Pending | K160016 | K083903 | |
| Intended Use/Indications for Use | | | | |
| Intended Use/
Indications for
Use | Stethophone v1 is
intended for
medical
diagnostic
purposes only. It
may be used for
detection and
amplification of
sounds from the
heart and lungs
with the use of
selective
frequency ranges.
It can be used on
adults undergoing
physical
assessment. | The StratoScientific
Steth IO
Stethoscope and
Phonocardiogram
Model 1.0 is
intended for
medical diagnostic
purposes only. It
may be used for the
detection and
amplification of
sounds from the
heart, and lungs
with the use of
selective frequency
ranges. It has been
tested for use on
adults undergoing a
physical
assessment. | The 3M™
Littmann®
Electronic
Stethoscope, Model
3200 is intended for
medical diagnostic
purposes only. It
may be used for the
detection and
amplification of
sounds from the
heart, lungs,
arteries, veins, and
other internal
organs with the use
of a selective
frequency. It can be
used on any person
undergoing a
physical
assessment. | Substantially
equivalent |
| Prescription/
OTS | Prescription | Prescription | Prescription | Same |
| Population Type | Adults | Adults | All types of patients | Same with Steth
IO, narrower
population than
Littmann 3200 |
| | | | | |
| | | | | which doesn't
affect safety and
performance for
the proposed
intended use |
| Principles of Operation | | | | |
| Form Factor | Device that is
held in the
Doctor's hand is
the form of the
smartphone | Device that is held
in the Doctor's
hand is the form of
the smartphone | Similar to a
traditional
stethoscope | Same as Steth IO.
Different than
Littmann 3200,
which doesn't
affect safety and
performance |
| Dedicated
Device vs.
iPhone | Operates on
iPhone
smartphone using
its hardware and
operating system | Operates on
iPhone smartphone
using its hardware
and operating
system | Dedicated
proprietary
hardware (chest
piece) | Same as Steth IO.
Different than
Littmann 3200,
which doesn't
affect safety and
performance |
| iPhone model
Compatibility | 6s, 6S Plus, SE
1st gen, 7, 7 Plus,
8, 8 Plus, X, XS,
XS MAX, XR, SE
2 generation, 11,
11 Pro, 11 Pro
Max, 12, 12 Pro,
12 Mini, 12 Pro
Max, 13 mini, 13,
13 Pro, 13 Pro
Max | iPhone 6, 7/8, 7+ or
8+, X | N/A | Stethophone v1 is
available for a
larger number of
iPhone models
than Steth IO,
which may affect
availability, but
doesn't affect
safety and
performance as
stethoscopes |
| Software
Platform | iOS | iOS | Windows, MacOS | Same as Steth IO.
Different than
Littmann 3200,
which may affect
availability, but
doesn't affect
safety and
performance as
stethoscopes |
| Sound Type | Heart, lungs | Heart, lungs | Heart, lungs,
arteries, veins, and
other internal
organs | Same with Steth
IO, narrower than
Littmann 3200,
which doesn't
affect safety and
performance for
the proposed
intended use |
| Signal Input
Method | Uses microphone
of the smartphone
to acquire a
sound | Uses microphone
of the smartphone
to acquire a sound | Uses microphone
of the stethoscope
to acquire a sound | Same as Steth IO,
equivalent to
Littmann 3200 |
| Audio Output
Method | Headphones | Headphones | Eartubes with
eartips | Same as Steth IO,
equivalent to
Littmann 3200 |
| Record and
Playback
Sounds | Yes | Yes | Yes | Same |
| Real-Time
Auscultation | Yes | Yes | Yes | Same |
| Filter Selection | Yes | Yes | Yes | Same |
| Digital Signal
Processing
(DSP) | Yes | Yes | Yes | Same |
| Display | Smartphone
screen | Smartphone screen | LCD display of the
device | Same as Steth IO,
equivalent to
Littmann 3200 |
| Sound
Visualization | Yes | Yes | Yes | Same |
| Technical Characteristics | | | | |
| Frequency
Response | Stethophone v1
picks up and
amplifies the
sound between
20 and 2000 Hz.
Based on the
selected audio
filter, specific
frequency ranges
are further
emphasized:
Bell filter
emphasizes
range from 25 to
300 Hz
Diaphragm filter
emphasizes
frequency
spectrum range
170-850 Hz,
Starling filter
works between 60
-1400 Hz | Steth IO has two
filters: Heart and
Lung. The specific
frequency filtration
of these filters
corresponds to
Stethophone's Bell
(high-cut filter) and
closely to
Stethophone's
Diaphragm and
Starling filters. This
correspondence is
based on frequency
response curves. | The Bell mode
amplifies sounds
from 20 - 1000 HZ,
but emphasizes
lower frequency
sounds between 20
- 200Hz.
The Diaphragm
mode amplifies
sounds from 20 -
2000 Hz but
emphasizes the
sounds between
100 - 500 Hz.
The Extended
Range mode
amplifies sounds
from 20 - 2000Hz
similar to the
Diaphragm Mode
but provides more
Low-frequency
response between
50 - 500Hz. | Substantially
equivalent |
| Volume Control | Yes | Yes | Yes | Same |
| Battery | Uses a built-in
battery of a
smartphone | Uses a built-in
battery of a
smartphone | Uses a built-in
battery of a
chestpiece | Same as Steth IO,
equivalent to
Littmann 3200 |
| Recording
Lengths | 20 sec | Up to 1 min | Maximum of 29
seconds for on-
board recording, up
to 1 min for
wireless recording
to computer
software | Substantially
Equivalent,
differences don't
affect safety and
effectiveness |
| Available Sound
Visualization | Spectrogram,
oscillogram | Spectrogram,
oscillogram | Spectrogram,
oscillogram | Same |
| Ability to Zoom | Yes | Yes | Yes | Same |
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Image /page/5/Picture/0 description: The image shows the logo for Sparrow Acoustics. The word "SPARROW" is written in a light blue sans-serif font, with a stylized image of a bird in the middle of the second "R". Above the bird are three curved lines, resembling sound waves. Below the word "SPARROW" is the word "ACOUSTICS" in a smaller, sans-serif font.
6
Image /page/6/Picture/0 description: The image shows the logo for Sparrow Acoustics. The word "SPARROW" is written in large, light blue letters, with a stylized image of a bird inside the "O". Below the word "SPARROW", the word "ACOUSTICS" is written in smaller, light blue letters.
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Image /page/7/Picture/1 description: The image shows the logo for Sparrow Acoustics. The logo features the word "SPARROW" in a light blue sans-serif font, with the "W" replaced by a stylized image of a bird inside of three concentric circles. Below the word "SPARROW" is the word "ACOUSTICS" in a smaller, sans-serif font.
The proposed device Stethophone v1 and the predicate devices Steth IO and Littmann 3200 share the same intended use, design, user functions and fundamental scientific operational technology. The devices are functionally the same: all three devices capture, amplify the sound, use frequency filters, visualize via two types of graphs (oscillogram and spectrogram), store records and allow auscultating heart and lung sound in real time. Software comparison and their validation support the equivalency claim. Performance and usability comparison testing was performed to support the equivalence claims.
-
Sparrow Acoustics Inc. submitted performance testing information in this 11. Performance Data: 510(k) to demonstrate safety and efficacy of Stethophone v1, to validate that the device meets predetermined specifications and performs according to pre-specified acceptance criteria, and to support the substantial equivalence determination.
Testing includes repeatability and reproducibility tests, performance tests using an anechoic chamber, internal tests run by a medical analysts' team, tests involving external medical specialists with auscultation experience, as well as a usability and performance study conducted by an independent medical facility. -
- Biocompatibility Not Applicable (Standalone Software) Testing:
-
Sterilization & Shelf-Not Applicable (Standalone Software). Therefore, it is a non-sterile 13. life Testing: device and shelf-life is not applicable to this device because of low likelihood of time-dependent product degradation.
-
- Electrical safety and Not Applicable (Standalone Software). Therefore, there is no source of electromagnetic risk for electrical safety or electromagnetic compatibility associated compatibility (EMC): directly with the device.
-
- Animal Study: Animal performance testing was not required to demonstrate safety and effectiveness of the device.
-
- Human Clinical Clinical testing was not required to demonstrate the safety and Performance Testing: effectiveness of the device.
-
- Statement of Stethophone v1 and the predicate devices Steth IO and Littmann 3200 Substantial share the same intended use, design, user functions and fundamental Equivalence: scientific operational technology. The devices are functionally the same. Software comparison and their validation support the equivalency claim. The differences that exist between the devices do not affect the relative safety and/or effectiveness.
Sparrow Acoustics believes the Stethophone v1 device and its predicates Steth IQ (Model 1.0) and 3M Littmann Electronic Stethoscope, Model 3200 used in conjunction with the Littmann StethAssist phonocardiogram software, are substantially equivalent.
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR §807.92.